Micro- and macrovasculair adaptations in patients with peripheral arterial disease during supervised exercise therapy: a MRI study

Completed

Conditions: atherosclerosis
stenosis
10003216

Registration Number: NL-OMON35278

Lead Sponsor: Radiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

•Intermittent claudication according to a psoitive Rose-Edingburgh questionnaire
•Rest ankel-brachial pressure index (ABPI) < 0,90 or 10% decline in ABPI after exercise
•Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements
•Able to ondergo exercise therapy

Exclusion Criteria

•Chronic or acute critical ischemia
•Treated by or planned for vascular surgery or
percutaneous transluminal angioplasty
•Recent onset <2 months
•Unable to perform treadmill exercise
•Diabetes mellitus
•Contra-indications for Gadolinium-enhanced MRI (i.e. renalclearance < 30 mL/min and known Gadoliniumallergy)
•Contra-indications for thigh cuff inflation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The clinical outcome (i.e. degree of rehabilitation) is expressed in terms of<br /><br>change in maximal and pain free walking distance and quality-of-life. The pain<br /><br>free walking distance will be measured conform the guidelines of the<br /><br>'inter-society consensus for the management of peripheral arterial disease<br /><br>(TASC II). Following this protocol, the primaire outcome measure consists of<br /><br>the walking distance up until claudicationpain arises. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in painfree walking distance before, after 3 and 6 months of therapy<br /><br>will be related to changes in micro- and macrovasculair adaptations that have<br /><br>been found on MRI assessments. MRI measures will be the degree of stenosis,<br /><br>collateralization, bulk blood flow to the common femoral artery, microvascular<br /><br>blood flow (expressed as Ktrans in mL/min/cm3) and dynamics of oxygen delivery<br /><br>during reactive hyperemia.</p><br>